Q4 2022 GeoVax Labs Inc Earnings Call
Good afternoon, and welcome everyone to the Geovax fourth quarter full year 2022, corporate update call. My name is Diego and I will facilitate todays call.
With me today are David Dodd, Chairman and CEO , Mark Reynolds, Chief Financial Officer, Mark Newman.
Chief Scientific officer Dr.
Kelly Mcbee, Chief Medical Officer.
And Doctor John Sharkey, Vice President business development at this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note. This conference is being recorded.
I will now turn the conference over to our host Gabby Deger Vena of C. G capital. Thank you you may begin.
Thank you. Please note the following certain statements in this presentation may constitute forward looking statements within the meaning of the private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances actual results may differ materially.
Really from those included in these statements due to a variety of factors including weather.
Backs can develop and manufacture vaccines at the desired characteristics in a timely manner gearboxes vaccines will be safe for human use kudos because vaccines will effectively prevent targeted infections in humans gearboxes vaccines will receive regulatory approvals necessary to be licensed and marketed geovax raise.
As required capital to complete vaccine development, there's development of competitive products that may be more effective were easier to use and G. Abaxis products do you that we'll be able to enter into favorable manufacturing and distribution agreement and other factors over which gearbox has no control.
Do you have actually assumes no obligation to update these forward looking statements and does not intend to do so more information about these factors is contained in <unk> filings with the Securities and Exchange Commission, including those set forth our risk factors in <unk> Form 10-K.
It is now my pleasure to introduce the chairman and CEO of Geovax David Dodd.
Good afternoon, and thank you for participating in the <unk> corporate update call.
Fourth quarter 2022 represented continued progress Virginia vaccines, we advanced the phase II clinical program to support a good captain a promising cancer therapy for patients with advanced head and neck cancers and G. E O C. M O four S. One our next generation COVID-19 vaccine focused only on.
<unk> needs of immuno compromised patients.
We also continued to progress our overall development stage programs. This includes our G O back Mark one immunotherapy currently in IND supporting studies also the preclinical studies evaluating adaptive in conjunction with immune checkpoint inhibitors continue to be encouraging with relevant data expected this year.
Throughout 2022 we strengthened our balance sheet during a very difficult investment environment, especially for the biotech industry. As a result of our successful financings last year. We've expanded our current clinical programs to include additional sites, while also adding near term opportunities related to our manufacturing process.
And the additional oncology programs.
Recently, we announced the expansion of our good depth in phase two clinical program with the activation of patient enrollment in the two additional sites in Edinburgh University and Thomas Jefferson University.
For our COVID-19 vaccine program, we implemented a novel mobile clinical research facility in Claremont, California to support our phase two COVID-19 vaccine booster trial.
Additionally, multiple sites are in the process of joining our phase two COVID-19 trial, among immuno compromised patients, including some potential sites outside the U S.
There is significant interest in participating in the evaluation of our novel COVID-19 vaccine targeting the high risk immunocompromised patient populations.
During the fourth quarter, we also announced the acquisition of the rights from the NIH, allowing <unk> to develop and commercialize their N V as a vaccine against monkey posture box in smallpox.
Our intent is to be the first and primary U S based supplier of the junior box N V. A vaccine against imports from small Cogs, resulting in expanded supply and access worldwide, especially related to low and middle income countries, which have consistently experienced significant difficulty in supply of many critical back.
Changing therapies.
Finally, we recently announced our successful progress towards becoming the first vaccine supplier using an atheist cell line based manufacturing process.
Difficult really expanding the yield and capacity N V E based vaccines.
This will allow us to reduce supply chain risk associated with the use of chicken eggs and to provide the means to greatly expand production called scale to address potential global needs again, I'm, especially related to lower cost alternatives for supply to the low and middle income countries.
Our mission is to provide immunotherapies and vaccines that improve lives worldwide, preventing or treating some of the world's most challenging cancers and infectious diseases.
Our business strategy of partnering and collaboration is anticipated to allow us to provide worldwide access to our products, while providing optimal value to our stakeholders.
We believe that the adapt and see them O four S. One.
Our other initiatives provide significant value expansion opportunities for the company, our shareholder and stakeholder, while providing compelling career development opportunities for the members of our team.
As a reminder, the adapter is a cancer therapy currently in our expanded multi site evaluation among patients suffering from advanced head and neck cancer.
The product has received orphan drug designation from the F D. A.
<unk> for the current clinical trial is from the F D. A orphan drugs clinical trials program.
Our focus is on completing the initial 10 patients study funded by the FDA.
We will review those results with the F D. A along with our recommendations for an expanded program. While also discussing with the FDA the potential for an expedited biologics license application filing.
We're excited about the outlook and promise of good depth within and pants head and neck cancers, as well as other opportunities and indications relative to the expanded use of good depth.
This includes the potential application of the underlying technology in conjunction with other therapies, such as immune checkpoint inhibitors and potential synergy with our internally developed G impacts Mark one tumor associated antigen approach <unk>.
Relative to commercialization, we anticipate partnering and collaborations that support a worldwide used for which business development activities have been initiated.
The vast array of unmet medical needs within oncology represent significant opportunities for <unk> to advance novel approaches such as that of good depth in therapy against multiple tumors. Good captain in conjunction with immune checkpoint inhibitors and the <unk> <unk> cancer immunotherapy approach addressing various cancer.
Patient needs worldwide as previously mentioned, we hold worldwide rights for the use with good depth in <unk> tumor associated antigen technologies in all indications.
Our plans include the successful development and commercialization globally in conjunction with collaborators and partners.
G E O C M O four S. One, which we refer to as see them Oh for US one is a phase II clinical development as a COVID-19 vaccine targeting both the antibody and cellular arms of the immune system.
The goal is to provide a more robust and durable protection than the currently authorized vaccines, especially for immuno compromised individuals. This vaccine holds promise over the current authorized vaccines from several critical areas of differentiation and value to various patients.
Sam O four S. One is being developed to address those patient populations of immuno compromised individuals currently in adequately serve body authorized back change and the various monoclonal antibody therapies.
A recent article in the New England Journal of Medicine address the critical need to address both antibodies and T cells relative to protection against Sars Covid, two infection and COVID-19.
Sam O four I wanted to specifically constructed to include a broader focus on the Sars COVID-19 two virus, including both the spike protein and the nucleocapsid protein, resulting in strong humoral and cellular immune responses.
As a result and induced a strong antibody and T cell responses.
Such immune responses were validated and reported last year in the lancet microbe publication of the phase one data.
Addressing the cellular immune responses to the inclusion of the nuclear capsid protein is especially critical among those patient populations, who have immune system with a blade or the ability to Mount a response to antibodies stimulation.
This includes patient populations with various blood cancers, HIV sickle cell anemia, kidney disease, autoimmune disease, and others with various co morbidities we.
We estimate at least 15 million such individuals in the U S alone and over 200 million patients worldwide.
We believe that CMO fourth one has the potential to address a critical worldwide medical need and commercial opportunity.
We also believe there's an opportunity for an expedited regulatory path make just for such a development program.
Well see them over the last one we also anticipate partnering and collaborations to occur for worldwide distribution, providing a novel vaccine in support of patients with such compromised immune systems.
Regarding 2023 milestones are focused this year includes accelerating efforts in support of the good depth and CMO for S. One phase II clinical programs moving the GFX N V. A vaccine related to imports in smallpox development and advancing our N V a manufacturing process into operational validation.
Yeah.
During the first half we anticipate reporting initial clinical results of the safety lead in for the CMO for US one immuno compromised trial.
Presentations are scheduled for the World vaccine Congress in early April the vaccine summit 2023 in late May as well as the Isacc site flow Cytometry International meeting in late May and <unk>.
[noise] until the recently reported side expansion of the good depth study, we anticipate reviewing initial data later this year.
Also this year, we anticipate reporting further preclinical information related to the use of the good depth of technology used in conjunction with immune checkpoint inhibitors.
Furthermore, we intend to provide updates relative to I N D supportive studies of our advancing Geovax Mach one tumor associated antigen therapy.
In early June our team will be actively participating in <unk> 2023.
During 2022 we strengthened our balance sheet, adding $37 million during a time when many biotech firms, we're furloughing programs and our people.
We feel that our capital development success reflects investor support and belief in the value and growth opportunities underway at G impact we continue to receive strong interest related to capital investment in development, which will evaluate but we're focused on execution towards our 2023 goals strengthening shareholder.
Value and achieving critical reporting milestone for our current development programs now.
Now I'd like to turn the presentation over to Mark where I'm always scared of Vacs, Chief Financial Officer for a review of our recent results and financial status marks.
Thank you David.
Starting with our income statement. The first thing to note is the lower grant revenues recorded during 2022 as compared to 2021.
Which is reflective of the wind down of our grants from the U S Army and then H for our Lassa fever, and COVID-19 preclinical programs as we focused attention on our clinical programs. We do however, intend to seek additional non dilutive government funding for our preclinical development programs in the future.
Research and development expenses were $9 1 million for 2022 versus $15 6 million for 2021, representing a decrease of $6 4 million.
It should be noted however that the 21 expense included $12 3 million of license fees and other upfront cost related to our licenses of CMO for us one and get up to <unk>.
Excluding these costs, our R&D expense actually increased by $5 9 million. These increases were planned unexpected as they were associated with new clinical trial activity for CMO forests, one and get dumped him, including manufacturing costs for clinical trial materials.
The increase was also reflective of higher personnel and consulting costs as we stacked up earlier in the year.
General administrative expenses were $5 million for 2022.
As compared to $3 6 million in 2021 with the increases associated with higher personnel consulting and patent costs.
So overall net loss for 2022 was 14 million or <unk> 83 per share versus $18 6 million in 2021 or three point.
A $3.04 per share.
Again, the increases during 'twenty two 2022 are primarily associated with ramp up of organizational infrastructure and other costs associated with the CMO for us one and conducting clinical trials.
Turning now to the balance sheet, our cash balances at December 31st were approximately $27 6 million as compared to $11 4 million at the end of 'twenty one the.
Change in our cash balances for 'twenty two is reflective of 19 million used in operating activities offset by proceeds from stock offerings in January and May with combined net proceeds to us of nearly $28 million and then an additional $7 6 million in proceeds from the actions of warrants during the third quarter of last year.
Our outstanding common shares now stand at $26 3 million.
In summary, we are well positioned to accelerate and advance our clinical programs with a cash runway sufficient to fund our operations and priority programs to the end of 2023.
Funding, our three ongoing phase two clinical programs and preparing for the next stages of development are the most significant use of our cash and our top financial priority.
I'll be happy to answer any questions during the Q&A and I'll now turn the call back over to David.
Thank you Mark.
My colleagues and I will now answer your questions joining.
Joining us for the Q&A session or a doctor's Mark Newman.
All of them are key and John Sharkey.
Our Chief Scientific Officer, Chief Medical Officer, and Vice President of business development, respectively.
I'll now turn the call over to the operator for instructions on the question and answer period.
Thank you.
Before we take questions I'm going to hand, the floor to Mark rentals for some comments. Thank you.
To take a minute to tell all of the listeners. Once you just heard was prerecorded by David and me.
Unfortunately, David had an unexpected a family emergency today and he is going to be I'm available to participate in the loft Q&A session.
But I still have with me today are Mark Newman.
John Sharkey and killing Mckee and we'll all do our best to answer any questions that might arise.
I'll turn it back to the operator now.
Thank you.
At this time, we will begin our question and answer session. If you would like to ask a question press star one on your telephone keypad.
Confirmation tone will indicate that your line is in the question queue you.
You May press the Star key followed by the number two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys. Once again to ask a question press star one on your telephone keypad.
Our first question comes from.
Jason Kolbert with Dawson James Please state your question.
Hi, guys. Congratulations on all the progress across a couple of questions across a couple of areas first on get depth in it.
What point do you think you hit it proof of concept, that's what I'm trying to understand phase one two trial at what point do you walk away and say yeah. This thing works.
Mark or Kelly, if which one of you take that question. Please.
Well. This is Kelly, let me, let me sort of start off.
That's that's really kind of a hard question to answer we have proof of concept.
In a general sense from from the.
The phase one study thats already completed and that we demonstrated that.
Injection.
Tumors with depth and followed by food Airbnb infusions.
Shrank shrank the tumors now.
Yeah. Yeah. This is palliative therapy. So we have no expectation that we're going to.
That we're going to improve overall survival or even necessarily linked in survival, but but we do have proof of concept already that this technology will shrink tumors.
Current study is designed to sort of follow up that initial trial.
By giving repeat administrations of <unk> and repeat.
With Airbnb.
Arab infusions following to activate the <unk>.
The protein inside the tumor.
And.
Sort of assess not only sort of what the safety profile or is it in with repeat administration, but to see whether we're seeing any.
It accelerated benefit or an expanded benefit is shrinking tumors.
And you know.
It's a small number of patients.
We've now enrolled eight of our target 10.
And.
Once that once the study is completed and we start looking at all the data.
So qualitatively as well as quantitatively I think we'll have a better sense for that.
And that information it should start to become available towards the end of the summer given sort of the timelines.
While itself.
Does that help answer your question Yeah, no no that does I mean, it establishes the timeline, we get it we're going to get a peak at any growth trend and see what the data looks like what what's the best case scenario that you'd like to see.
The best case is is we take our data package to the FDA and they they look at it and tell US well you know if you can give us similar data in additional you know a reasonable number of patients. So we don't know what that reasonable number it would be we were initially.
Hoping it would be somewhere in the neighborhood of 20 to 40, but it's probably going to be more than that but you know then then we could achieve an accelerated approval for this is an unmet medical need.
Sure.
But.
Again.
It sort of depends on what the data looks like when we finish finish the trial and what the environment at the at the FDA is in terms of the accelerated approvals for these kinds of therapies at the time that we presented to them.
Okay fair enough.
<unk> similar question on the Covid two vaccine program.
Two phase III trials, what's the next focal point.
With that we should be looking at in terms of that dataset.
Well so so the two trials that we have ongoing.
One of them is in healthy volunteers.
Healthy individuals as the heterologous booster and where.
About between a third and a halfway through enrollment with the addition of our new clinical site, we anticipate.
<unk>.
Accelerating enrollment dramatically hope to have that study fully enrolled within the next couple of three months.
At worst.
And you know given the follow up that the primary endpoint.
The primary immune.
Marker endpoint is.
A month or so after the.
After the boosters. So we should start seeing some of that data hopefully.
Bye.
We're three quarters, well say say early quarter four of this year.
The the study that we've got ongoing in patients with hematologic malignancies is is a much slower pace study.
We've we've not been able to enroll that study as quickly as we had anticipated at the city of hope.
National Medical Center, where it was begun and for that reason, we've we've begun in listing support of multiple other academic medical centers and buy.
The summer time, we should have a handful of those.
Lined up and enrolling patients so.
I wouldn't anticipate any.
Any significant readouts of that for.
Gosh.
My best guess a year.
Something like that.
These patients it's hard to it's hard to find patients didn't meet the eligibility criteria for this for this trial.
Okay Fair enough and my last question is really understanding the importance of the M. B a manufacturing process.
What I'm thinking here is that what you're saying is you know in the event that there is another pandemic the ability to be able to make a vaccine at scale high capacity high yield quickly becomes critical obviously youre differentiate it from an mrna Prost.
S, which is a pretty rapid process too, but you're making the point that you're getting away egg based vaccine technology is.
Is is something in the past and you've now.
Got this critical piece in place is that is that understanding correct.
I would add to that.
Yeah. This is Marc.
Mark Newman, let me comment on that one sure yeah that is the goal here you know the mrna is a platform as you can imagine where you can.
Really enables you to do a rapid response, so there's that diversity has seen a response and you know building up vaccine capabilities. So the cell lines production gives us large scale, but it's also the idea is to get back to a kind of a normal world of vaccines, where you know a childhood.
Vaccines or are given at a young age and you hope never to get never to get sick. The rest of your life type of thing and that's what we're looking at for our our products. So larger scale knee larger scale manufacturer would mean that met needed to meet that type of distribution. So it's.
You know we're focused on COVID-19, so you're always being compared to the mrna vaccine groups, but we're actually targeting that feel totally differently. So it's it that's that's the issue it's it kind of.
We can do small scale and certainly address what's the current technology.
Smaller niche types of patient populations, but really expand it which is what's in our plans that will fit into the cell production base systems.
Yeah. Thank you that really weird clears that up for me a lot congratulations on all the progress I hope David as well bye. Thank you.
Our next question comes from Vernon Bernardino with H C. Wainwright. Please state your question.
Hi, Thanks for taking my question most of them have already been asked and answered, but just wanted to follow up on Jason's question.
Regarding get that and that's the kind of efficacy.
We might expect from the phase two.
You mentioned the.
These patients had been enrolled.
And perhaps expect some data at the end of summer, but what kind of data would that be would that be just data in which you confirmed.
Good that's been shrinks tumors or is there some other kind of efficacy data you expect to announce.
Well I mean, where we are we are measuring I mean.
Our our endpoint measures include sort of.
You know we we graded these these these tumors under <unk> 1.1.
And we will be taken tumor measurements will look we will be looking at.
Not only the sort of quantitative.
Impact on injected tumors, but the potential.
The effect on this distant.
Just in tumors that were not injected.
And.
It it's it's it's as much to to give us a sense for or some confidence in that in that what we're doing is is actually benefiting patients.
In a meaningful way just in terms of improving somewhat their quality of life.
But also sort of giving us some guidance.
With regard to direction for follow on studies.
There's no doubt that we're going to have to add additional patients to them.
Due to the 10 that we will have at the end of this trial, but whether that means we will be able to for example.
Uh huh.
Increase the amount of Fludarabine, we're able to give patients to give it a chance to be.
To activate more of the good depth and inside the tumor tumor masses that are injected whether that means we can.
Either dial up or dial back the amount of inject.
Injected.
Adenovirus to carriers.
The activated activating protein into the tumors you know those kinds of questions, we'll get some sense for where we can take this the steady as we go into additional patients is.
Is that does that help you.
Yes, and as a follow up do you have any expectations on the harmony repeat cycles, maybe possible, especially.
When you're also getting fludarabine.
Yeah.
Well, so so each cycle right now involves injection of a good depth and 333, the depth and injections over a two day period followed by Hum.
Sure.
Three days of therapy now.
And it's five cycles for each up to five cycles for each patient.
Now.
Whether we can add add additional cycles, whether additional cycles would be useful.
We really don't know that yet and again that's you know these these.
These are questions that we want to explore as we as we progress through development and redevelopment program, but we don't have enough information right now to be able to make that make that decision.
Terrific and you expect to discuss.
Data from the 10 patients.
With the S T a.
What do you think that'll be a this year.
Yeah, I mean, we are obviously sort of constrained by by how quickly we can enroll these final two patients.
And then if you sort of follow if he if these fine we'll take the patients followed the entire lifecycle program.
You know what we were looking at basically six months from the time that the last patient is is enrolled so.
Give us.
A month or so here too to analyze the data in and pull it together schedule a meeting with the FDA.
So we're hoping we'll be able to get to get in front of them by the end of the year, but there are.
Some factors that are sort of beyond our control in that regard.
Perfect. That's very helpful and thanks for taking my questions.
Mhm.
Our next question comes from Jason Mccarthy with Maxim Group. Please state your question.
Hi, This is Joanne me on the call for Jason Mccarthy. Thanks for taking the question just two for me as most of my questions have already been answered, but I, firstly, I guess sort of funny broader perspective.
You guys have any numbers on I guess, the proportion of patients who are getting regular boosting and be vaccination and would you expect this to be sort of the addressable population for your vaccine I'm curious to hear your thoughts.
Okay.
Well when you mean patients you mean.
You mean, our hematologic malignancy population or who.
Who you're talking about specifically for the Covid related to the Covid vaccine I guess, how many people are you know up to date and actively you know getting boosters and I guess, if your COVID-19 vaccine that you're currently not being would be addressable population of patients.
Well I mean, I would I would anticipate that that.
Given given the impact of this disease can have on an immunocompromised populations.
Populations of patients virtually all of them will be getting you know regular boosters with mrna vaccines. According to the schedule prescribed by the CDC and the AR and the.
<unk>.
You know cancer societies.
But we don't have any specific numbers.
In Hain, what we do know is that the response that these patients.
Generate two mrna vaccines is.
Is suboptimal compared to that seen in normal healthy individuals and that they remain vulnerable to contracting.
Severe illness, when they get infected with this virus.
Great appreciate the color and moving along I guess to the head and neck cancer trial, how large do you think the child would go in terms of enrollment and what kind of response rate do you think would be clinically meaningful to advance the program.
Well yeah, Yeah, you've just asked two questions that we're gonna be gonna be curious.
Curious to hear from the FDA about.
You know, we don't really know right now what they're going to require in order for us to to to be granted an accelerated approval.
We have some estimates from some of our consultants that range anywhere from.
80 to 120 patients, but whether that's really what they're thinking right now we don't know.
And in terms of what sort of en pointe towards sort of readouts.
You know again, we don't know what the emphasis is going to be whether it's gonna be sort of tumor response in terms of shrinkage, whether it's gonna be a quality of life measure some combination of that.
And between now and our meeting with the FDA. The FDA, we're going to solicit input from a number of regulatory specialists that have been working in this area to give us some thoughts and recommendations about what to present, what you propose.
Got it I appreciate you taking all the time to provide updates and congrats again on the quarter.
Our next question comes from Robert Leboyer with Noble capital markets. Please state your question.
Good afternoon, I was hoping that you could discuss some of the things.
In the depth and trial and specifically the use of the checkpoint inhibitors that was mentioned early earlier there was a mention of the the dosing regimen.
I was curious as to whether you are going to have separate arms for the checkpoint inhibitors or all all patients or how you were going to go about testing it but.
Either.
Listen good afternoon, either alone or in combination.
Yeah. So so well I mean fundamentally we don't we don't have a study design specifically in mind at this point in time, however, we recognize the potential that adding a checkpoint inhibitor offers to a therapy.
Like adaptive.
I mean, they're sort of biologically plausible rash.
Rationale for doing this and there are other.
Therapeutic agents in trials in head and neck cancer.
That are sort of capitalizing on this on this concept.
At the present time, so so we have some ideas about how to go about doing this but we don't have any specific design in mind at this time.
The preclinical work that's ongoing is is with our with our collaborators at Emory University.
In which they they've demonstrated in animal models, some very encouraging results, which.
I think are going to support them.
Yeah, moving forward and how to move forward.
Our thinking at this time and this is not meant to commit us in it.
Any way there I'm thinking at this time is that offering adept and plus a checkpoint in the context of new adjuvant therapy is a very appealing approach and we intend to explore that.
Extensively as we discuss taking the program down the road in in multiple different directions.
Yeah.
Okay. Thank you very much.
Mhm.
Thank you just a reminder to the audience to ask a question press star one on your telephone keypad to remove yourself from the queue Press star two.
Our next question comes from Kumar Roger with Roth Capital. Please state your question.
Thanks for taking my questions. So first one with regard to the Moc, one I N D filing.
What needs to be done that before and also the timing.
And with regard to the got up in private what are you seeing in terms of what the screen failure rate and what should we expect in terms of data like basketball.
Well as well.
I'll take the adapt in one and then Mark and Mark will address the muck one question, but so so we're not presenting anything at ESCO.
Yeah, we are.
I'm I'm going to be going to that meeting and availing myself with the opportunity to interact with many of the key opinion leaders in the head and neck cancer field.
To pick their brains to see.
So to see what our what the state of the art is with.
Yeah.
Using so.
So a therapeutic interventions either alone or in conjunction with Hum.
Checkpoint inhibitors and other immunologic sort of.
Hum.
Well I don't want to see adjuvant, but but yeah.
The nation that with other other immunologic stimulators stimulants.
And.
So there's no there's no data that there's going to be presented at Astro because we don't really have a complete data set to be able to proceed.
And what was your other question about good afternoon before I give it back to me and I was wondering what youre seeing in terms of square screen failure rate Oh, yeah.
Yeah.
So.
That that that's really a hard question to answer because.
The patients that are offered to us by our our site investigators.
Are those that are sort of at the end of their of their other therapeutic options.
And you know patients tend to be.
Pre identified at some point well in advance of the time that they're really ready to enroll in our trial and whether they they start whether they show a response to our current therapeutic regimen that their own or whether they they find themselves in.
And such.
Straights.
Because of their underlying disease that they don't qualify because of.
Abnormal.
Blood, chemistries or or cardiac failure or whatever.
It's it's it's it's it's kind of all over the place and so we don't really we don't really see.
If patients aren't patients are screened unless they sort of get to the point, where they are in a position where the investigator thinks theres a reasonable chance that they could could could enroll in a trial now once they get to that point I would guess that our screen failure rates, probably somewhere in the neighborhood of 25% to 50%.
Okay, that's great.
Mhm.
Thank you.
And our next question comes from Jeffrey Cross with Crystal Research. Please state your question.
Conferences, you're attending.
For good depth in or for or for any of it.
Oh, Yeah, yeah yeah.
We are just not SaaS go to yes.
Right, Yes, there's going to be data presented at the World vaccine Congress.
In early April .
There is gonna be date on TMO forest, one theres going to be data presented at the vaccine summit in Boston.
I guess that's early June .
Well maybe late May.
CMO for S. One and then.
There is a flow cytometry.
Sorry, Cytometry conference in May where some data.
That's sort of the.
Some of the lab.
With more technical lab stuff.
Seated with our with our trial, there's going to be presented as well.
Fantastic I know you've been working very hard to move that along so that's great news and the second question is with regard to the manufacturing.
And having that as one of your goals.
If one wants to look at your manufacturing validation and we want to have and just say you hope to have it by a certain date, what would you say the percentage of working towards that is complete now I'm not asking for what the specific side and if you say you are 50%, they're 60% there 80% there just roughly.
Mark John that's yours.
What.
So.
We have different we have different viral vector vaccines right, so where we're in the the Ebola field, we've got O. Four S. One which is the other COVID-19 first step towards a universal Covid vaccine and you match each of these well. We are we are at least evaluating each of these with different <unk>.
Cell lines for expression systems, and that's a step wise process. So the first thing you want to know is that a particular virus will grow in a particular satellite and sometimes they don't sometimes the answer causes of toxicity and the cell lines can be DUC origin or chicken origin, there, they're all tumor cell type of lines.
But with slightly different genetic variations based on the birds you get them from so you March through the series of events and say, which cell line supports which virus now for all four S. One we've actually got a choice we've taken that along to the point, where we're comfortable we can make a choice you whenever we wanted.
Two they are produced with different manufacturing technologies, which week you know they are out there. We would just have slacked, how we wanted to do it. So we're actually at the stage now where we're talking business terms and that would be you know John Sharkey I don't know that we're going to share any details on that but that one is ready to go.
We have another candidate.
Other research level product, where I think we would know exactly where we're able to go but it's it's it's still in the mouse model of its second kind of a secondary approach more of a universal COVID-19, but we're not focusing on that as much as the O. Four S. One so you know what.
Where are there, but I think you would have to say that each one of these is likely to be a specific paired system. It would be great. If we could find a single manufacturer at a single cell line that would do it all for us and I'm hopeful that maybe we'll get lucky, but realistically we have seen bear.
Creation and so we we're doing doing the right stuff each of the steps for each product. So the lead product we're ready perfect. We could make a decision yep perfect perfect that got approaching completely concur with what you said one final question is you.
Youre seeing a lot of interest and a lot of movement out there amongst pharma companies in our coverage and pharma, we're seeing still a strong interest in partnering with novel companies with unique and differentiated technologies that are game changers, you still seeing a lot of interest for potential partners.
Yeah, I'll take that one.
Yeah, Hey, Jeff. Thanks for the question, so actually that was it.
Boswell earlier this week as a.
Bio spring European partnering meeting and as you know we started discussion with companies.
Whereas year with bio and what I can say is that.
I'm seeing more and more interest and once people understand that they were trying to work and I mean, the reality is the world has gotten a little card COVID-19 the general population and so on.
I'm often asked do we need another COVID-19 vaccine, but when you kind of lay out where we're working in immune compromised.
The current vaccine just are not adequate to protecting people many people already.
People engaged now.
Are we at the point, where I can say somebody is going to snap it up.
Can't say that but I will say that people are gauging with following up with us in August .
And so I think where we're working.
We're succeeding at convincing people, there's a real need.
And that there's a lot of attractive.
Options in this space and that.
These are patients who are normally under active treatment are being medically managed are being managed by specialist which means that smaller billboards detailed them. There they are easier to identify and get to there's a lot of positives from a commercial side and working in this space.
Appreciate your cat enough. Thanks for taking the questions keep up the good work. Thank you.
Thank you there are no further questions at this time I'll turn the floor back to Mark Reynolds for closing remarks.
Yes. Thank you.
I just wanted to conclude the call by thanking everybody for participating your interest really is greatly appreciated by all of us and.
I'll say that our focus for this year for 2023 is one execution on reporting updates and progress for conducting and our CMO forests, one clinical programs as well as the other development programs we have underway.
And for all of US It is a great pleasure serving shareholders to as I say got truthfully and being in being part of this team.
So with that I'll conclude and I'll just tell everybody have a good day. Thank you.
Thank you. This concludes today's conference all parties may disconnect have a great evening.